MSCI Course Listing

Required Courses

This course is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles with explanation and analysis of selected portions of the Code of Federal Regulations (CFR), applicable to clinical research during the new drug development process. The case study approach is used in this course since the drug development industry translates these regulations into both written and unwritten standards, practices, and guidelines.

Each session will use activities to expand the interpretation of the regulations, further integrating real-life issues into the classroom. In order to ensure that classroom learning is linked with the students’ work experiences, there will be an outside project required which will incorporate the course work with the on-the-job situations, and a final presentation to share the learning with the entire class.

Course explains the regulatory requirements for healthcare products, that is, drugs, biologics, diagnostics, and devices. Intended for those interested in regulatory affairs or in the clinical evaluation, development, manufacture, testing and/or commercialization of these products. Provided is an in-depth review of the pertinent FDA regulations and guidelines and links these to the scientific and logistical activities involved in taking a product from research to market.

Content and preparation of regulatory submissions, including an Investigational New Drug Application (IND), an Investigational Device Exemption (IDE), a New Drug Application (NDA), a Biologic License Application (BLA), a Pre-Market Approval Application (PMA), and a 510K PreMarket Notification are described. International requirements for health care products are also reviewed.

This course is designed for Clinical Research Associates and other students with no prior experience with statistics who want to utilize computer software in performing statistical analysis. Topics include the collection, classification, and presentation of descriptive data; the rationale of hypothesis testing; experimental design; t-tests; correlation and regression analysis; and analysis of contingency tables. Laboratory course.

This course covers important epidemiologic principles necessary for designing clinical research studies. Topics include bias, confounding, developing the research question, defining an appropriate study population, choosing outcome measures, clinical research ethics and regulation, sample size determination, and statistical analysis issues. Students will design and present a clinical research study during the course.

The goal of this course is to provide students experience in reading and evaluating current literature that may be pertinent to the origination, design, implementation and evaluation of clinical research . The course is conducted in a seminar format.

Each week, students read and critically analyze assigned readings of recent literature which may be relevant to clinical research about human diseases. Teams of students present their reviews of the assigned article and then lead the discussion during which the entire class participates. This format provides an opportunity to learn to critically evaluate the scientific literature and to develop oral presentation skills. Students will also be required to write three article critiques. Pairs of articles will be available for critique, each pair consisting of an article from the biomedical literature and a corresponding article from the newspaper or internet.

A student would only register for this course if they plan on using the practicum towards the 32 credit requirement. Please see your academic advisor to get this approved before you register for this course.

Var cr [up to 4 cr], Fall, Spring and Summer.

Elective Course Options

A minimum of 14 credits in elective coursework: A wide variety of courses offered in the Division of Graduate Medical Sciences will count toward elective credit. A minimum of 14 credits must be taken as electives, directed study or practicum. Up to 4 credits may be taken as the practicum. Please ensure that your electives are approved by your academic adviser before registering for them.